Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00794326
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2008-11-18
Brief Title:
Clinical Evaluation of Low Sodium Peritoneal Dialysis PD Solution on Hypertensive Patients Treated With PD
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Fresenius Medical Care Deutschland GmbH
Study Overview
Official Title:
Multicentric Parallel Controlled Randomized Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDOne
Brief Summary:
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis PD solution PDsol 12 in comparison with a conventional already marketed solution Gambrosol trio 40 in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodiumwater balance
Detailed Description:
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality
Moreover the poor control of dry weight and sodiumwater balance results in increased morbidity A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid which allows achieving a negative sodium balance without altering water balance
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure andor medication for hypertension defined as the primary endpoint
In order to evaluate the main criteria blood pressure a 24hours Ambulatory Blood Pressure Monitoring ABPM will be performed twice during the study at Baseline and at 8 weeks of treatment according to the EMEA guidance recommendations for anti-hypertensive treatments In addition the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension
The study is designed in three periods
Run-in period during 1 month a reference product Gambrosol Trio 40 one bag day will be used by all patients This period is dedicated to train the patient in using of study product to stabilize the patient in the PD treatment and to randomize the patient by performing the 24h ABPM
Efficacy Safety period during 6 months each patient will be treated with one of two product PDsol 12 studied product or Gambrosol Trio 40 reference product during 6 months The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid
Follow-up period during 2 months without treatment This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect
Moreover the poor control of dry weight and sodiumwater balance results in increased morbidity A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid which allows achieving a negative sodium balance without altering water balance
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure andor medication for hypertension defined as the primary endpoint
In order to evaluate the main criteria blood pressure a 24hours Ambulatory Blood Pressure Monitoring ABPM will be performed twice during the study at Baseline and at 8 weeks of treatment according to the EMEA guidance recommendations for anti-hypertensive treatments In addition the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension
The study is designed in three periods
Run-in period during 1 month a reference product Gambrosol Trio 40 one bag day will be used by all patients This period is dedicated to train the patient in using of study product to stabilize the patient in the PD treatment and to randomize the patient by performing the 24h ABPM
Efficacy Safety period during 6 months each patient will be treated with one of two product PDsol 12 studied product or Gambrosol Trio 40 reference product during 6 months The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid
Follow-up period during 2 months without treatment This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2007-005365-35 | None | None | None |